BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLINK(TM)CONTINU-FLO SOLNSET 3INJ SITES 10DPM

    MDR report key: 1820442 · Received August 30, 2010

    Report

    Report Number
    6000001-2010-02872
    Event Type
    Malfunction
    Date Received
    August 30, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 4, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF BAXTER'S INVESTIGATION, A FOLLOW UP MEDWATCH WILL BE SUBMITTED. BATCH REVIEW PERFORMED: NO EXCEPTION WAS OBSERVED DURING THE MANUFACTURING. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER RETURNED ONE USED SAMPLE FOR EVALUATION. AN UNDER WATER LEAK TEST AT 8PSI WAS PERFORMED ON THE SAMPLE AND THE REPORTED CONDITION WAS CONFIRMED. THE SET LEAKED AT THE CHECK VALVE. A BATCH REVIEW WAS PERFORMED ON THE REPORTED LOT WITH NO DEVIATIONS FOUND. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. AS THIS COMPONENT IS SUPPLIED BY AN EXTERNAL SUPPLIER, A SUPPLIER CORRECTIVE ACTION REPORT (SCAR) WAS ISSUED FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED OF A SLOW LEAK COMING FROM THE CHECK VALVE WHILE ATTACHED TO A PREGNANT PATIENT SET TO RECEIVE A PITOCIN DRIP TO INDUCE LABOR. THE MEDICATION LEAKED ONTO THE PATIENT. THERE IS SOME QUESTION WHETHER THE PATIENT ALSO SUFFERED FROM RENAL DYSFUNCTION. THIS INCIDENT OCCURRED DURING PATIENT USE. THE BABY DID NOT APPEAR TO BE AFFECTED. NO ADDITIONAL INFORMATION WAS AVAILABLE. NO PATIENT INJURY OR MEDICAL INTERVENTION OCCURRED. THIS REPORT IS FOR THE PATIENT (MOTHER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERLINK(TM)CONTINU-FLO SOLNSET 3INJ SITES 10DPM SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - SINGAPORE SR10E17092

    Patients

    Seq Age Sex Outcome Treatment
    1